(22 days)
The Traveler™ Portal Vein Access Set is intended for transjugular liver access in diagnostic and interventional procedures.
Each Portal Vein Access Set contains a 5F MPA catheter, a puncturing tool that comes in the following variations: 0.038" Stylet with a 5Fr Stylet Catheter (separated with a removable spacer clip) or a 21ga Needle/5Fr Catheter or a 16ga Needle/7Fr Catheter (both are separated with a removable spacer clip) and a bending tool. The 14ga stiffening cannula with cannula sheath and the 16ga needle has a curved end, with a directional handle that indicates the direction of the curve.
The provided text is a 510(k) summary for the Traveler™ Portal Vein Access Set. This document is a premarket notification to the FDA, demonstrating that a new device is substantially equivalent to a legally marketed predicate device. The primary purpose of this submission is not to prove the device's efficacy through a clinical study demonstrating performance against specific acceptance criteria, but rather to show that it is as safe and effective as an existing, cleared device.
Therefore, the document does not contain information on "acceptance criteria for device performance" in the way one would typically find for a novel device requiring a clinical trial with statistical endpoints. Instead, it describes non-clinical functional and material testing to demonstrate performance parity with the predicate device after a modification (removal of two components).
Based on the provided text, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
The document states: "Test results demonstrate that all acceptance criteria were met; therefore, the device meets the established product specifications." However, it does not provide a table detailing specific quantitative acceptance criteria or the measured performance values for each test leveraged from K201489 or for the new verification testing.
Instead, it lists the types of non-clinical tests performed:
| Type of Testing | Specific Tests Mentioned (if any) | Reported Performance / Outcome |
|---|---|---|
| New Verification Testing (due to modification) | Functional Fit | Acceptance criteria met. Device meets established product specifications. |
| Hemostasis | Acceptance criteria met. Device meets established product specifications. | |
| Leak | Acceptance criteria met. Device meets established product specifications. | |
| Simulative Use (including component compatibility) | Acceptance criteria met. Device meets established product specifications. | |
| Leveraged Performance Testing (from K201489) | Radiopacity | Acceptance criteria met. Device meets established product specifications. |
| Echogenicity | Acceptance criteria met. Device meets established product specifications. | |
| Corrosion Resistance | Acceptance criteria met. Device meets established product specifications. | |
| Dimensional & Functional Fit | Acceptance criteria met. Device meets established product specifications. | |
| Tensile Strength | Acceptance criteria met. Device meets established product specifications. | |
| Torque Strength Test | Acceptance criteria met. Device meets established product specifications. | |
| Liquid Leakage | Acceptance criteria met. Device meets established product specifications. | |
| Air Leakage | Acceptance criteria met. Device meets established product specifications. | |
| Burst Pressure | Acceptance criteria met. Device meets established product specifications. | |
| Flow Rate | Acceptance criteria met. Device meets established product specifications. | |
| Simulative Use - performance testing including dimensional, surface and compatibility of components | Acceptance criteria met. Device meets established product specifications. | |
| Luer Functional Testing | Acceptance criteria met. Device meets established product specifications. | |
| Shipping Test | Acceptance criteria met. Device meets established product specifications. | |
| Resistance to Fracture Testing | Acceptance criteria met. Device meets established product specifications. | |
| Biocompatibility Testing (leveraged from K201489) | Cytotoxicity (ISO 10993-5) | Acceptance criteria met. Device meets established product specifications. |
| Sensitization (ISO 10993-10) | Acceptance criteria met. Device meets established product specifications. | |
| Intracutaneous Irritation (ISO 10993-10) | Acceptance criteria met. Device meets established product specifications. | |
| Acute Systemic Toxicity (ISO 10993-11) | Acceptance criteria met. Device meets established product specifications. | |
| Material Mediated Pyrogen (ISO 10993-11) | Acceptance criteria met. Device meets established product specifications. | |
| Hemocompatibility (ISO10993-4): ASTM Hemolysis – Direct and Indirect Contact, Complement Activation, SC5b-9, In Vivo Thrombogenicity, Platelet and Leucocyte counts, Partial Thromboplastin Time (PTT) | Acceptance criteria met. Device meets established product specifications. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists only non-clinical (bench) and biocompatibility testing. It does not specify sample sizes for these tests. It also does not mention any clinical data, human subjects, or data provenance (country of origin, retrospective/prospective), as clinical testing was not required.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This document pertains to a 510(k) submission for a device modification, where substantial equivalence is demonstrated through non-clinical testing. There is no mention of human experts (e.g., radiologists) or ground truth establishment relevant to an AI/imaging device validation. The "ground truth" here would be defined by the specifications and standards for the mechanical and biological properties of the device, assessed through laboratory testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This document describes non-clinical and biocompatibility testing of a medical device, not a human reader study or AI performance evaluation where adjudication methods would be used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This submission is for a physical medical device (catheter introducer) and its modification, not an AI/imaging device that would perform a MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This submission is for a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this type of device and submission, the "ground truth" for the non-clinical tests is established by engineering specifications, international and national standards (e.g., ISO, ASTM), and validated test methods. Compliance with these predefined specifications and standards serves as the "ground truth" for demonstrating that the device meets its design requirements.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" as this is not an AI/machine learning device.
In summary: The provided document is a 510(k) summary for a Class II medical device (catheter introducer) that has undergone a minor modification. The demonstration of safety and effectiveness relies on non-clinical (bench) and biocompatibility testing, leveraging data from the predicate device and adding specific tests for the modified components. It does not involve AI, clinical trials, or human evaluations as would be the case for AI-based medical devices. Therefore, many of the requested points related to AI/human reader studies are not present in this document.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).